Senior Scientist, CMC Analytical Development

Mariana Oncology; Watertown (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in personalized medicine and radiopharmaceuticals is seeking a Senior Scientist in CMC Analytical Development. The ideal candidate will possess expertise in analytical chemistry and method development, focusing on the safety and efficacy of radiopharmaceutical products. Responsibilities include method validation and compliance with regulatory guidelines, collaborating with cross-functional teams, and maintaining analytical instruments. This role offers an opportunity to contribute to innovative solutions in the field of medicine.

Qualifications

• 5–7+ years of hands-on experience in analytical chemistry, preferably in drug development.
• Strong understanding of GMP, GLP, and regulatory requirements.

Responsibilities

• Perform analytical testing of radiopharmaceuticals using various techniques.
• Develop, validate, and optimize analytical methods for radiopharmaceutical compounds.
• Ensure compliance with ICH, FDA, and EMA guidelines.

Skills

Analytical Chemistry

Problem Solving

Communication

Education

Bachelor’s or Master’s degree in Chemistry

Pharmaceutical Sciences

Tools

HPLC

GC

TLC

ICP-MS

LC-MS

Gamma Spectroscopy

Job description

Senior Scientist, CMC Analytical Development

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Job Description

We are seeking an experienced Senior Scientist, CMC Analytical Development to join Mariana’s CMC organization, advancing personalized medicine and radiopharmaceuticals. The ideal candidate will have a strong background in analytical chemistry, method development, validation, quality control, and radiochemistry, with a focus on ensuring the safety, efficacy, and compliance of radiopharmaceutical products. Responsibilities include method development, validation, and routine analysis of radiopharmaceuticals in accordance with regulatory guidelines.

Reporting Line

Vice President, CMC

Responsibilities

• Perform analytical testing of radiopharmaceuticals using techniques such as HPLC, GC, TLC, ICP-MS, LC-MS, and gamma spectroscopy.
• Develop, validate, and optimize analytical methods for the characterization and quantification of radiopharmaceutical compounds.
• Conduct stability studies and ensure compliance with ICH, FDA, and EMA guidelines.
• Prepare and review technical documents, including SOPs, protocols, and reports.
• Collaborate with cross-functional teams to support product development, manufacturing, and quality assurance.
• Troubleshoot and maintain analytical instruments, ensuring accurate and reliable results.
• Ensure adherence to GMP, GLP, and radiation safety protocols.
• Stay current with industry trends, regulatory requirements, and advancements in analytical chemistry and radiopharmaceuticals.

Qualifications and Skills

• Bachelor’s or Master’s degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, or related field.
• 5–7+ years of hands-on experience in analytical chemistry, preferably in drug development, radiopharmaceuticals, or regulated environments.
• Proficiency in analytical techniques such as HPLC, GC, TLC, ICP-MS, LC-MS, and gamma spectroscopy.
• Strong understanding of GMP, GLP, and regulatory requirements for radiopharmaceuticals.
• Experience with method development, validation, and transfer.
• Experience in drafting method protocols, execution, and final report drafting for approval.
• Excellent problem-solving skills and attention to detail.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Company Principles

• Building a Legacy
• Execution Excellence
• Courage of our Convictions

Additional Details

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Research, Analysis, and Information Technology